Laparoscopic port site closure tool

ABSTRACT

A device is provided to assist in closing an incision through body tissue that comprises a tubular body sized for introduction through the incision and carrying a plurality of stabilizer elements at the distal end thereof. The stabilizer elements are configured to be deployed within the body cavity to engage the lowermost tissue layer. In one method, the device is pulled with the stabilizer elements deployed to retract the body tissue away from adjacent body structure. In another method, a plurality of needle tips carrying sutures are guided through the body tissue to a retention device at the ends of the stabilizer elements. With the needle tips captured in the retention devices, the device is withdrawn from the incision so that the sutures form ligatures that can be tied off to close the incision.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/176,616, filed on Jul. 7, 2005, which claims priority to U.S.Provisional Application No. 60/598,798, filed on Aug. 5, 2004, thedisclosures and figures of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

The invention relates generally to surgical suturing devices, and moreparticularly to intra-abdominal suturing devices designed for closingpuncture wounds created by surgical trocars and similar puncturingdevices.

Minimally invasive surgery is a revolutionary new technique that hasreplaced many standard invasive surgical operations requiring largeincisions with operations utilizing very small incisions. In thistechnique, access to the surgical field is made through very smallincisions (generally 5-18 mm in diameter) via a surgical trocar. Thesetrocars typically have a diameter of, for example, between 3 mm and 30mm and a length of about 150 mm (6 inches). Tubes are then insertedthrough the incision to permit the further introduction of miniaturizedinstruments and laparoscopes that can be manipulated by a surgeon whileviewing the surgical field on a television monitor. This technologyaffords the patient considerably less pain and disfigurement, and a muchfaster recovery. The rapid return of the patient to productive activityfurther reduces the ultimate cost of the surgery.

Although trocars are widely used to puncture the abdominal wall as afirst step in minimally invasive surgical techniques, such use createsseveral clinical problems. The very small size of the incision and thesomewhat awkward access to the interior facies of the tissuessurrounding the incision make closure of the incision problematic andtime consuming. For example, one method requires the introduction of apre-threaded suture needle approximately 3-5 mm from the edge of theoriginal trocar incision. The surgeon views the needle via a laparoscopeas it pierces the abdominal wall. The surgeon then grasps the ligaturein the pre-threaded needle with a forceps, eventually secures it, passesit to a needle that has been introduced on the opposite side of thesurgical defect, and withdraws the needle up through the other side ofthe incision, through the abdominal wall, and ties off the suture. Theknot is generally tied under the skin to avoid residual externalscarring.

Because the surgeon cannot directly visualize the exact position of theneedle until after it has passed completely through the abdominal wall,several insertions may be required in order to place the needle at anideal and proper distance from the trocar incision. The distance fromthe needle location to the original incision is critical in that theneedle must be far enough from the trocar incision to secure an optimalamount of abdominal wall tissue. If the needle distance from theincision is too small, an insufficient amount of tissue will be securedwith a consequent risk of inadequate closure of the surgical defect.This may result in subsequent herniation of the omentum or bowel.However, if needle distance from the point of the original trocarincision is too great, incision closure will result in excessive tissuebeing grasped, and the patient will be left with an unsightly “knot” oftissue. Aside from attendant awkwardness and the problems resultingtherefrom, this method is time-consuming and often produces onlymarginal closure integrity.

Another difficulty associated with this mode for closure is associatedwith obese patients who present considerable fat in the abdominalregion. Because the abdominal wall of an obese patient may be severalinches thick, it is extremely difficult, tedious and time consuming toapproximate the fascial tissues with a suture. Often times, followingremoval of a large trocar, the puncture site needs to be enlarged toaccomplish this, thus negating some of the advantages of endoscopicsurgery previously discussed.

Another common technique for closing a trocar incision comprises there-approximation of the fascia and subcutaneous fat by means of a smallneedle introduced through the trocar skin incision from outside the bodyat the termination of the procedure. The difficulty with this techniqueis that the edges of the fascia are not easily visualized, with theresult that tying the ligature may or may not effectively re-approximatethe edges of the fascia. Certainly the peritoneal defect is noteffectively closed by this approach because the suture is not placeddeeply enough.

Often times, closure of the trocar incision is nothing more than skindeep, the deeper layers of the fascia remaining free. Failure to makecomplete closure of the incision entails a significant risk of delayedbleeding (occurring after the abdomen is deflated and the tamponadingeffect of the inflated abdomen ceases), or the possibility of herniationof either omentum or bowel into the subcutaneous opening.

Occasionally, the peritoneal defect may be approximated by atraditional, curved-needle suture ligature that is placed from withinthe abdominal cavity under direct vision. The knot is then tied eitherby means of an intra-corporeal or extra-corporeal knot-tying technique.This approach is rarely used because it is cumbersome, requires a highlevel of skill, and is still not optimal as it ensures only that theperitoneum is closed, closure of the more exterior fascia being purelyspeculative.

In view of the foregoing there is a clear need for a closure tool orsuturing device, and a method of incision closure, that is accurate andreliable, and that does not require an excessive amount of time tocomplete. There also exists a need for a surgical device and method thatcan be utilized by surgeons having various skill levels.

SUMMARY OF THE INVENTION

In view of these needs, the present invention contemplates a closuretool that in the first instance applies pressure to the suture site frominside the abdominal cavity, and in the second instance provides asimple, quick-operating mechanism for passing the suture through thebody tissue.

In one aspect of the invention, a device is provided for assisting inthe closure of the interior tissue layers of a patient. In oneembodiment, the device comprises a tubular body configured forintroduction through the incision, the body having a distal end and aproximal end and a length between the distal and proximal ends sized sothat the distal end may be positioned adjacent the innermost tissuelayer while the proximal end is accessible outside the patient. At leastone stabilizer element is movably supported at the distal end of thetubular body, the stabilizer element movable relative to the tubularbody between an insertion position substantially in alignment with thetubular body for insertion through the incision and a stabilizingposition in contact with the interior surface of the innermost tissuelayer. The device further comprises means for holding the stabilizerelement in the stabilizing position. In this position, the tubular bodymay be pulled outward relative to the incision so that the stabilizerelement engages and retracts the tissue layers relative to bodystructures adjacent the incision.

In the preferred embodiment, the stabilizer elements include a pair ofwings pivotably mounted to the distal end of the tubular body. The wingsare supported on an axle extending between a pair of legs extending fromthe lower edge of the tubular body. A torsion spring helps bias the legsto their extended or stabilizing position. An actuator is provided thatis accessible outside the patient that can be manipulated to move thestabilizer elements from their insertion position to their stabilizingposition, and then to a removal position when it is desired to withdrawthe device from the incision.

In certain embodiments, the stabilizing elements include a retentiondevice at a free end thereof. The retention device is configured toretain a needle tip. The tubular body defines at least one guide channelconfigured to receive a needle tip carrying a suture. The guide channelis arranged so that a needle tip passing therethrough will be inalignment with the retention device when the stabilizing element is inits stabilizing position.

Thus, in one method of the invention, a needle guide is used to advancea needle tip carrying a suture through body tissue disposed between thetubular body and the stabilizer elements. Once the needle tip reachesthe stabilizer element, the tip is captured by the retention device, sothat the suture is in effect tied to the stabilizer element. With theneedle tips captured in corresponding stabilizer elements, the elementsare moved to a removal position so that the device may be removed fromthe incision. As the device is removed, the sutures are pulled throughthe tissue and the incision to form ligatures at multiple locations. Theligatures may then be cut from the device and tied off in a known mannerto close the incision.

In one aspect of the invention, the needle tips are removably engaged toa corresponding needle driver. Once the needle driver has pushed theneedle tip into the retention element, the driver is removed. In anotherembodiment, the needle driver is configured to drive the needle tipthrough an arcuate path in which the needle tip moves from the tubularbody, through the body tissue on opposite sides of the incision and backinto a retention element formed in the tubular body itself.

In accordance with one embodiment of the invention, a method is providedfor assisting in the closure of an incision in body tissue comprising:introducing a tubular body through the incision; deploying a stabilizingelement between the body tissue and body structure adjacent theincision; and with the stabilizing element deployed, pulling the tubularbody to retract the body tissue from the body structures. With the bodytissue retracted, the adjacent body structures can be more easilyvisualized.

In another aspect, the method contemplates the stabilizing elementsincludes forming a space between the stabilizing elements and a loweredge of the tubular body sufficient for ingress of the body tissue intothe space. This aspect facilitates advancement of a needle tip carryinga suture therethrough to be captured by the stabilizing element. Thus, afurther aspect of the inventive method comprises advancing the needletip and suture from the tubular body, through body tissue between thetubular body and toward the stabilizing element, and then capturing theneedle tip with the suture at a free end of the stabilizing element.Once captured, the stabilizing elements can be moved to a removalposition with the needle tip captured at the free end thereof. Thetubular body is withdrawn from the incision with the needle tip capturedso that the suture forms a ligature through the body tissue at theincision.

It is one object of the present invention to provide a closure devicethat facilitates the closure of an incision through body tissue of apatient. Another object of the invention is achieved by features thatallow for a minimal number of steps to introduce and operate the closuredevice to pass sutures through the body tissue.

One particular benefit of the invention is that it is readily usablewhere the tissue layers are relatively deep. Another benefit is that theclosure device facilitates closing the incision subcutaneously. Afurther benefit of the invention is that multiple sutures, preferablytwo, may be passed through the tissue and withdrawn simultaneously toform closure ligatures. Yet another benefit of the present closuredevice is that the device protects abdominal structures from thesuturing needle as all suturing activities occur between the devicewings and the fascia. Other objects and benefits of the invention willbecome apparent upon consideration of the following written descriptionand accompanying figures.

DESCRIPTION OF THE FIGURES

FIG. 1 is a side representation of a laparoscopic port extended throughan incision in a patient.

FIG. 2 is a side representation of the laparoscopic port of FIG. 1 witha suture closure tool of one embodiment of the invention extendingtherethrough.

FIG. 3 is a side representation of the port and closure tool shown inFIG. 2, with the laparoscopic port partially withdrawn.

FIG. 4 is a side representation of the port and closure tool shown inFIG. 3 with stabilizing elements of the closure tool depicted in theiroperative position.

FIG. 5 is an enlarged partial cross-sectional view of the distal end ofthe closure tool shown in FIGS. 2-4, with the stabilizing elements shownin their insertion/retraction position.

FIG. 6 is an enlarged partial cross-sectional view of stabilizingelements in an alternative embodiment of the invention.

FIGS. 7 a-c are sequential representations of the deployment ofstabilizing elements in yet another embodiment of the invention.

FIG. 8 is an enlarged partial cross-sectional view of stabilizingelements in another embodiment of the invention.

FIGS. 9 a-b are side views of a suture closure tool according to afurther embodiment of the invention, shown with the stabilizing elementsin their insertion position.

FIGS. 10 a-b are side views of the suture closure tool depicted in FIGS.9 a-b, shown with the stabilizing elements in their operative position.

FIGS. 11 a-b are enlarged perspective views of alternative embodimentsof a tissue facing portion of a stabilizing element for use with any ofthe embodiments shown above.

FIGS. 12 a-b are side views of the suture closure tool depicted in FIGS.9 a-b, 10 a-b, with the stabilizing elements in their removal position.

FIG. 12 c is a bottom view of the suture closure tool shown in FIG. 12b, as viewed in the direction of the arrows.

FIGS. 13 a-e are side views of the suture closure tool shown in FIGS.9-12 in use to pass a suture through the patient tissue to close theincision.

FIG. 14 is a side representation of an alternative suture closure toolusing a pre-curved needle.

FIG. 15 is an enlarged view of a pre-curved needle for use with theclosure tool shown in FIG. 14.

FIG. 16 is an enlarged view of a loading tube for introducing thepre-curved needle of FIG. 15 into the suture tool shown in FIG. 14.

FIG. 17 is a side view of a suture closure tool according to a furtherembodiment of the invention using a substantially continuous needle.

FIG. 18 is a top view of the closure tool shown in FIG. 17.

FIG. 19 is a side view of a suture closure tool modified from theembodiment shown in FIG. 17.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

For the purposes of promoting an understanding of the principles of theinvention, reference will now be made to the embodiments illustrated inthe drawings and described in the following written specification. It isunderstood that no limitation to the scope of the invention is therebyintended. It is further understood that the present invention includesany alterations and modifications to the illustrated embodiments andincludes further applications of the principles of the invention aswould normally occur to one skilled in the art to which this inventionpertains.

One phase of a typical laparoscopic procedure is shown in FIG. 1. Inparticular, a laparoscopic tool L defining a port P is extended into asmall incision I. The incision passes through multiple tissue layers foraccess to the patient's abdomen, for instance. Thus, the laparoscopictool extends through the skin, subcutaneous and muscle layers, as wellas the various fascia layers to provide access to the insufflatedabdomen. The laparoscopic port P provides a point of entry for asurgical tool, visualization instrumentation and other tools andinstruments well known in the field of laparoscopic surgery.

Naturally, once the laparoscopic tool L is removed and the procedurecomplete, the incision I must be closed. The present inventioncontemplates a closure tool 10 that is configured in one embodiment topass through either the laparoscopic port P, as shown in FIG. 2, orthrough the port incision I. The tool 10 generally includes an uppercannula 12 and stabilizer elements 14 that are disposed at the distalend of the cannula 12. An actuator 16 is operable to deploy thestabilizer elements 14 into their operative position, as shown in FIG. 4once the laparoscopic tool L has been withdrawn or removed. In thisoperative position, the stabilizer elements 14 are displaced outwardlybeyond the confines of either the cannula 12 or the laparoscopic tool L.In this position, the entire closure tool 10 can be pulled upward sothat the stabilizer elements 14 exert pressure on the innermost fascia Fand slightly compress the tissue layers around the incision I.

The stabilizer elements 14 provide the ability for the surgeon to liftthe abdominal wall to clear adjacent organs to decrease the risk ofinjury to adjacent organs. In certain procedures, the abdominal wall maybe lifted as much as about 2.0 cm. or more which is useful to improvevisibility or surgical tool access. This feature is particularly helpfulfor procedures involving patients with thick subcutaneous tissue layers,such as obese patients. In another beneficial attribute, the slightcompression of the tissue layers caused by pulling the abdominal wallupward using the stabilizer elements 14 may facilitate passage of asuture needle through the tissue.

The present invention contemplates that the stabilizer elements 14 arepivotably mounted to the upper cannula 12 so that the elements can pivotfrom their insertion position, as represented in FIGS. 2-3, and theiroperable position, as shown in FIG. 4. In one embodiment, the elements14 may be situated at substantially right angles relative to theinsertion direction, as depicted in FIG. 4. Alternatively, the elements14 may be at a non-perpendicular angle in their operable position (see,for instance, FIG. 13 a). In the embodiment shown in FIG. 5, thestabilizer elements 14 are mounted to the cannula 12 at a pivot mount18. In this embodiment, the pivot mount is carried at the end of an arm20 that preferably spans the diameter or across the width of the cannula12.

The actuator 16 is slidably disposed within the upper cannula 12 and isconnected to the stabilizer elements by a pair of pull wires 22. Thepull wires 22 are engaged to the stabilizer elements 14 at a point 24remote from the pivot mount 18 so that an upward force exerted on thepull wires 22 by the actuator 16 will cause the elements to pivot aboutthe pivot mount. As the stabilizer elements pivot, they swing upward, asindicated by the directional arrows in FIG. 5. The distal end of thecannula 12 can define opposing openings 25 to receive the inboardportion of the stabilizer elements when they are in their operativeposition.

In the position shown in FIG. 5, the stabilizer elements can be insertedinto the incision I, either directly or through the laparoscopic tool P.In addition, the closure tool 10 can also be removed with the stabilizerelements 14 in that position. Thus, the present invention contemplatesthat the stabilizer elements can be returned to their aligned positiondepicted in FIG. 5. In one specific embodiment, a torsion spring (notshown) can be disposed within the pivot mount 18 to bias the stabilizerelements 14 to their insertion position shown in FIG. 5. When it isdesired to deploy the stabilizer elements, pulling the actuator 16exerts a moment on the pivoted end of the elements against the biasingforce of the torsion spring. When it is desired to remove the tool 10from the surgical site, the actuator 16 can be depressed relative to thecannula 12 so that the torsion force of the spring naturally tends topivot the stabilizer elements 14 to the insertion/removal position.

In an alternative embodiment, shown in FIG. 6, the stabilizer elements14′ are pivotably mounted by pivot arms 20′ to pivot mounts 18′ definedon the interior of the upper cannula 12′. The actuator 16 is connectedby push rods 22′ to the stabilizer elements at mounting points 24′. Inthis embodiment, the push rods 22′ are generally rigid but pivotablymounted at their ends to the actuator 16 and the mounting points 24′.When the actuator 16 is pushed downward, as indicated by the arrow, thestabilizer elements 14′ swing outward into the operative position shownin FIG. 4. When it is desired to retract the elements 14′, the actuatoris pulled upward, which in turn pivots the elements 14′ in thecounter-direction until they are aligned with the cannula 12′, as shownin FIG. 6.

A related concept is depicted in FIGS. 7 a-c. In this embodiment, thecannula 50 carries a tube 52 that supports an actuator plunger 55. Theproximal end of the tube 52 may be flared (not shown) to provide afinger gripping location to facilitate depressing the plunger 55 and toprovide a purchase point to pull or retract the tool 50, as describedherein. The plunger is connected to actuator wires 54 that are fixed ata mounting point 58 to each of the stabilizer elements 56. Thestabilizer elements 56 are pivotably mounted to a pivot mount 60 thatextends from the base of the cannula 50. In the specific embodiment, thepivot mount 60 is situated between opposite legs 61 projecting from thecannula. The stabilizer elements 56 include pivot arms 62 that aremounted on an axle 63 that extends between and is supported by the legs61 at the pivot mount.

The stabilizer elements 56 start in their retracted position shown inFIG. 7 a to permit insertion through the incision. Once the elements 56are visualized beneath the tissue layers, the actuator plunger 55 isdepressed so that the actuator wires 54 push the stabilizer elements 56outward about the pivot mount 60, as shown in FIG. 7 b. In thisembodiment, the actuator wires are bendable but stiff enough to permittransmission of an axial force from the plunger 55 through the wiresagainst the free ends of the stabilizer elements 56.

As the plunger is pushed further, the wires push the stabilizer elements56 until they reach their deployed position shown in FIG. 7 c. In thisposition, a locking pin 64 can be extended through aligned pin bores 65,66 and 67 in the upper cannula 50, tube 52 and actuator plunger 55,respectively. The pin thus holds the actuator, and therefore thestabilizer elements, in the position shown in FIG. 7 c so that thestabilizer elements can be pulled upward into the tissue, as describedabove. When it is desired to remove the closure tool, the locking pin 64is removed and the actuator plunger 55 is either pushed furtherdownward, in which case the elements 56 pivot downwardly, or the plungeris pulled back, in which case the elements 56 pivot upward back to theiroriginal position shown in FIG. 7 a. It can be appreciated that in thisembodiment, as well as in the embodiment of FIG. 6, no torsion spring orbiasing element is required.

An alternative embodiment that does utilize a biasing element is shownin FIG. 8. In this embodiment, a cannula 30 includes downwardlyprojecting legs 35 that support a pivot mount 34 for the stabilizerelements 32. The elements include pivot arms 36 that are supported on anaxle 37 supported by the legs 35. A torsion spring 38 may be disposedbetween the pivot arms 36 of the two stabilizer elements 32, or eachelement can include a torsion spring disposed between it and the pivotmount. The torsion spring 38 is configured to bias the stabilizerelements 32 to their deployed position, as shown in FIG. 4.

In this embodiment, the stabilizer elements 32 are held in theirinsertion position, shown in FIG. 8, by locking wires 42 that fit withinrecesses 40 in the tips of the elements. The locking wires 42 areconnected to an actuator 44 that may be retracted or moved upwardly torelease the locking wires 42 from the recesses 40. Once released, thetorsion spring 38 causes the stabilizer elements 32 to automaticallypivot about the pivot mount 34. A movable limit stop may be incorporatedinto the pivot mount 34 to hold the stabilizer elements in the deployedposition. These limit stops may then be removed to allow the elements tocontinue to pivot until they are in line with the cannula 30 to permitremoval of the closure tool.

Another embodiment of the invention that utilizes s torsion spring atthe pivot mount is depicted in FIGS. 9-12. The closure tool 70 includesa body or cannula 71 that is sized to fit within the incision or throughthe laparoscopic tool P. The cannula 71 is formed by an annular wall 72(FIG. 12 c) that is preferably formed or molded in a medical gradematerial. In one specific embodiment, the body 71, as well as most ofthe components of the closure tool 70, is formed of an inexpensive,readily disposable material, such as a medical grade plastic.

The closure tool 70 includes stabilizer elements 74 that are configuredto bear against the inner fascia of the patient's tissue from within theinsufflated surgical site and to provide pressure to compress the tissueduring suture insertion. The stabilizer elements 74 are furtherconfigured to move from the compact insertion position shown in FIGS. 9a-b, to the extended operating position shown in FIGS. 10 a-b, to theremoval position depicted in FIGS. 12 a-b. An actuator 76 is provided toaccomplish moving the stabilizer elements between the three positions.

In the illustrated embodiment, the stabilizer elements are supported onthe cannula 71 at a pivot mount 78. The pivot mount 78 is offset fromthe cannula by support legs 79. An axle 80 extends between the legs 79to support the stabilizer elements. Each stabilizer element 74 includesa wing 82 that is supported on a pivot hub 84 defining an axle bore 85(FIG. 11 a) for mounting on the axle 80. In this preferred embodiment, atorsion spring 88 is disposed on the axle 80 between the two pivot hubs84. The ends of the torsion spring 88 may be embedded or locked withinthe hubs in a known manner that is sufficient to reliably rotate the twowings 82 of the stabilizer elements 74. The torsion spring 88 iscalibrated to fully rotate both wings to the removal position shown inFIGS. 12 a-b, in the absence of any restraint against rotation of thewings. Although a single torsion spring 88 is provided between the twohubs 84, each hub can be provided with its own torsion spring thatoperates between the hub and a corresponding support leg 79. However, asingle torsion spring may be preferred for ease of assembly and reducedspace requirements.

The actuator 76 restrains the two wings 82 from pivoting under theinfluence of the torsion spring 88. In the illustrated embodiment, theactuator 76 includes an actuator bar 90 that passes diametricallythrough the cannula 71, and more specifically through opposite actuatorchannels 98 defined in the cannula wall 72. Knobs 91 at the oppositeends of the bar 90 retain the bar within the channels 98 and provide formanual engagement to operate the actuator 76. Preferably, the knobs 91are grasped between the thumb and forefinger to manipulate the actuatorbar 90 within the two channels 98.

A pair of flexible cables 93 are fastened at one end to the actuator bar90 and at the opposite end to the spool hub 95 of a correspondingpivoting wing 82. The cables 93 are configured to be wound around arespective spool hub 95 when the stabilizer elements 74 are rotated fromtheir insertion position shown in FIGS. 9 a-b to their removal positionillustrated in FIGS. 12 a-b. In other words, the torsion spring 88 isoperable to rotate each pivot hub 84 and associated spool hub 95 togradually wind the corresponding flexible cable onto the spool.

Of course, when the flexible cables 93 are held in position by theactuator bar 90, the cables resist further rotation of the pivotingwings 82. Thus, when the actuator bar 90 is situated at the top of theactuator channel within the insertion detent 100, the flexible cables 93are taut and work against the torsion spring 88 to hold the wings 82 intheir insertion position shown in FIGS. 9 a-b. When it is desired tomove the wings to their operative position of FIGS. 10 a-b, the actuatorbar 90 is manually moved from the detent 100 to the detent 102, therebymoving the cables toward the spool hubs 95. The torsion spring rotatesthe spool hubs to take up the slack in the cables 93, and at the sametime pivot the wings 82 to the operative position. Finally, when it isnecessary to remove the closure tool 70, the actuator bar 90 is manuallymoved from the detent 102 to the detent 104 at the end of the actuatorchannel 98. The slack in the cables 93 is again taken up by rotation ofthe spool hubs 95 under the influence of the torsion spring 88. When theclosure tool 70 has been removed, the stabilizer elements 74 can bereturned to their initial closed position (FIGS. 9 a-b) by pulling theactuator bar up the channel 98 to the first detent 100. This movementunwinds the cables 93 from the corresponding spool hubs 95 causing thehubs to rotate against the torsion springs.

In order to prevent inadvertent movement of the actuator bar 90, theactuator channel 98 includes a ramp portion 101 between the first detent100 and the second detent 102, as well as a comparable ramp portion 103between the second and third detents 102, 104, respectively. The rampportions are inclined upward or away from the first and second detentsso that the actuator bar 90 must be pulled upward to dislodge the barfrom the corresponding detent.

As thus far described, the closure tool 70 includes means forstabilizing the tool relative to the tissue and incision. Moreover, thestabilizer elements 74 provide means for lifting the tissue layers awayfrom intra-peritoneal structures. As explained above, lifting thetissues away from organs, for instance, may help in visualizing thesurgical site as well as help in providing clear access to internal bodystructures. The stabilizer elements also provide some compression of thetissue around the incision, which can facilitate passage of a sutureneedle through the tissue. The closure tool thus provides means fordirecting a suture through the tissue and capturing the suture so thatwhen the tool is removed the ends of the suture are accessible to tieoff and close the incision. Thus, in accordance with one aspect of theillustrated embodiment, the cannula wall 72 defines a pair ofdiametrically opposite needle guide channels 108, as best seen in FIGS.10 b and 12 c. The guide channels are arranged so that a straight needlepassing through the channels will approach the tip of each pivoting wing82 when the wings are in their operative position shown in FIG. 10 b.

The guide channels define an entry opening 109 at the side of thecannula 71 that is positioned to reside sufficiently above the skin ofthe patient when the closure tool 70 is in its operative position. Theopening 109 can be conical to facilitate introduction of a suture needleinto the channel. Each channel 108 further defines an exit opening 111at the base of the cannula and aligned with the top of the correspondingpivoting wing 82 in the operative position of FIG. 10 b. It isunderstood that the guide channels 108 and their corresponding entry andexit openings are aligned to avoid encroachment with the othercomponents of the closure tool 70. The exit openings are also preferablyaligned so that a suture needle exiting the channels will contact thefascia of the incision below the skin layer. Preferably, the exitopenings 111 are arranged so that the suture needle will first penetratethe subcutaneous tissue SC (FIG. 1). With this preferred arrangement,the support legs 79 for the pivot mount 78 supporting the extended wings82 have a length approximately equal to the nominal thickness of themuscle layer M and fascia F beneath the subcutaneous tissue SC. It canbe appreciated that when the closure tool 70 is in its operativeposition, a portion of the cannula 71 is disposed within the upperportion of the incision I.

In another aspect of the needle guide channels 108 define a suture slot113 (FIG. 12 c) along the length of each channel. The suture slot 113 isnarrower than a suture needle, but sufficiently wide to allow a sutureto pass through as the suture needle is advanced along the channel. Thesuture slot 113 thus facilitates accessing the free ends of the sutureonce the suture has passed through the tissue layers and the closuretool removed from the incision.

As indicated above, the cannula 71 is preferably molded from a medicalgrade plastic. With this construction, the needle guide channels 108 canbe integrally formed with the wall 72 with a web 115 spanning the spacebetween the wall and the channels. The webs 115 support the guidechannels so that they hold their position relative to the extendedpivoting wings 82.

In accordance with a further feature of the invention, each suture 122is carried by a needle tip 120, as shown in FIG. 13 a. The needle tip120 is essentially simply the tip of a suture needle, absent the needleshaft. The suture 122 is fastened to or held by the needle tip in aknown manner, such as by crimping the suture within a slot formed in thetip. The suture must be fastened to the needle tip in a manner thatprevents its separation from the needle tip 120 during use of theclosure tool 70. It is understood that once the ligature loop has beencompleted at the incision the suture can be cut at the needle tip,leaving a free end of the suture.

Since the suture is carried only by a needle tip, the inventioncontemplates a needle driver 124 that carries and propels the needle tipthrough the guide channels 108 and through the tissue layers. The needledriver 124 can be provided with a bore 125 to removably receive a baseportion 126 of the needle tip. Other methods for removably engaging theneedle tip 120 to the needle driver 124 are contemplated provided thatthe driver can be easily removed from the needle tip once the needle tipand suture has been passed through the tissue layers.

The closure tool 70 thus provides means for directing a suture needlecarrying a suture toward the extended wings 82. The wings 82 arethemselves provided with means for capturing the suture needle, andultimately one end of the suture. In one embodiment, the tip of eachpivoting wing 82 includes a capturing device 130, as shown in FIG. 1 a,that is configured to capture the needle tip 120 and hold it fromretrograde movement as the wings are pivoted to their removal positionof FIGS. 12 a-b and as the closure tool 70 is removed from the incision.In this embodiment, the capturing device includes a guide ring 132 thatis configured to guide the needle tip toward the center of the capturingdevice 130. The device includes a resilient flap structure 134 at thecenter of the guide ring with a center opening 136 to receive the pointof the needle tip. As the needle tip is advanced toward the capturingdevice, the guide ring aligns the point of the needle tip with thecenter opening 136. As the needle tip is pushed further it pushes pastthe resilient flaps which separate slightly but collapse about the baseportion 126 of the needle tip once the tip has passed completely throughthe center opening. The guide ring is preferably slightly conical todirect the needle tip to the center opening even if the needle tipcontacts the wing 82 slightly offset.

In an alternative embodiment, a capturing device 140 is provided asshown in FIG. 11 b that is rectangular rather than circular inconfiguration. In this embodiment, the device includes a series ofresilient flaps 142 with separation lines 143 providing areas in whichthe flaps can be separated for passage of the needle tip. These flaps142 operate like the retention flap 134 described above to capture theneedle tip and prevent its retrograde movement. In both embodiments ofFIG. 1 a and FIG. 11 b the corresponding retention flaps hold the needletip as the needle driver 124 is disengaged from the needle tip.

In certain embodiments, the tip of each pivoting wing 82 can be providedwith a gripping feature, such as the ridges 148 depicted in FIG. 11 b.This gripping feature may enhance the engagement of the stabilizerelements with the tissue as the wings are pulled upward to exertpressure on the body tissue. The material of the gripping feature, orridges 148, must be capable of achieving solid purchase on therelatively slick surface of the fascia F. In one embodiment, thegripping feature is formed of a rubber or a SILASTIC® material.

Referring now to FIGS. 13 a-e, the use of the closure tool 70 can beunderstood. In FIG. 13 a, the wings 82 have been deployed into theiroperative position and the closure tool 70 pulled back to slightlycompress the tissue layers. The closure tool is situated so that theexit opening of each needle guide channel 108 is aligned so that theneedle tip 120 can pass directly into a portion of the subcutaneoustissue layer from inside the incision. The closure tool may bepositioned to close the anterior fascia, the posterior fascia, or both.

The location of the body tissues shown in FIG. 13 a illustrates abeneficial feature of the invention. In particular, in one aspect of theembodiment, the tubular body 71 of the closure tool 70 presents an outerdiameter that is larger than the effective diameter of the incision I.Once the wings 82 are deployed, the body tissue at the incision walltend to “flow” into the space between the tubular body 71 and the wings82. A similar effect may be achieved if the tool 70 is deployed througha trocar or laparoscopic port P (FIG. 1) with a diameter greater thanthe effective diameter of the incision I. This tissue ingress enhancesthe ability to pierce the tissue layers with the needle tip 120,particularly for plural needle paths and suture sites.

With the closure tool so positioned, a needle tip 120 is loaded onto aneedle driver 124, with the suture 122 fixed to the needle tip and thefree end of the suture disposed outside the wound. The needle driver isthen pushed toward the incision I to penetrate the tissue layers. As canbe seen in FIG. 13 a, the needle tip is aimed toward the capturingdevice 130 of the wing 82.

In FIG. 13 b, the needle tip 120 has traversed the capturing device 120and is held in position against its removal. The slight compression ofthe body tissue facilitates penetration of the needle tip so that thetip should be substantially aligned with the capturing device 130 whenit reaches the wing 82. As reflected in FIG. 13 b, a needle driver 124is also used to drive a needle tip into the capturing device on theopposite wing 82 so that a suture 122 has been threaded through oppositesides of the incision I.

With both needle tips 120 retained in a corresponding capturing device130, the corresponding needle driver 124 is separated from the needletip, retracted and removed, as depicted in FIG. 13 c. Each suture 122may be temporarily positioned within the needle guide channels 108 ormay be loose adjacent the cannula 71; however, the distal portion of thesuture has been driven through the tissue around the incision.

In the ensuing step, the wings are moved to their removal position,illustrated in FIG. 13 d, in the manner described above. Specifically,the actuator 76 is moved to the lowest detent 104 so that the torsionspring can unwind and rotate the wings 82 until they are generallyaligned with the longitudinal axis of the cannula 71. It is understoodthat as the wings rotate downwardly, they pull each suture 122 with themso that excess suture 123 is drawn through the closure site. At the sametime, the cannula 71 may be pushed slightly into the incision to drawadditional suture material into the site.

With the pivoting wings 82 in their removal position, the entire closuretool 70 may be removed from the incision, as shown in FIG. 13 e. As thetool is withdrawn from the wound the excess suture 123 is pulled backthrough the incision to form a ligature loop. At this point, the suturecan be cut at the needle tip 120 so that the free ends of each suture122 are accessible outside the incision. The two sutures can then betied off in a conventional manner to close the incision, and moreparticularly to close the fascial layers of the incision.

It can be appreciated that the closure tool 70 provides an easy andefficient mechanism for forming a subcutaneous ligature loop and closingan incision, especially in the abdomen. The device provides means fordriving two sutures through the tissue without requiring direct visionof the process from within the body cavity. However, it is preferablethat the process be visualized and that the position of the sutures beverified under direct vision before the opening is closed. In typicalsurgical practice, only two sutures are required to completely close anincision, so only a single operation of the tool 70 is required.However, if desired, additional sutures may be introduced at theincision. In a preferred embodiment, the closure tool 70 may be“reloaded” with a second set of needle tips 120 and sutures 122 and thetool repositioned within the incision I. In an alternative embodiment,an additional pre-loaded closure tool can be passed through the sameincision with the sutures 122 in the position shown in FIG. 13 e. Thesecond closure tool placement may be aligned with the wings 82 at ninetydegrees to the position of the wings of the first tool to pass twoadditional sutures at the ninety degree interval. The same procedureoutlined in FIGS. 13 a-e may be followed with this additional tool toprovide four sutures to close the incision.

It is understood that in the preferred embodiment, each closure tool 70is disposable and is intended to be discarded after each patient useonce the sutures have been placed. Each closure tool is preferablyprovided pre-loaded—i.e., with each needle tip engaged to acorresponding needle driver, and each needle driver positioned within acorresponding needle guide channel. The needle driver can be configuredto combine the driver for the suture needles on the opposite sides ofthe tool into a single driver so that only a single movement of theneedle driver is necessary to penetrate the tissue and lodge each needletip into a corresponding capturing device.

In the embodiment of FIGS. 9-13 a straight needle arrangement isutilized. In an alternative embodiment, a pre-curved needle or needledriver may be used. Thus, in one embodiment depicted in FIG. 14, aclosure tool 150 includes a cannula 151 that defines a guide channel 152for receiving a suture needle. The closure tool further includesstabilizer elements 156 that are connected to the cannula 151 by way ofa pivot mount 158. As thus far described, the closure tool 150 can beconstructed in a manner similar to the tool 70 described above. Forinstance, the stabilizer elements can include a torsion spring to biasthe elements to their retraction position (see FIG. 13 d). The tool 150may also incorporate an actuator similar to the actuator 76 of theclosure tool 70 (see FIG. 12 a).

However, unlike the tool 70, the closure tool 150 incorporates a needlecapture device 160 in the body of the cannula, as shown in FIG. 14. Thecapture device 160 may be configured similar to the capture devices 130and 140 shown in FIGS. 11 a and 11 b, respectively. Thus, the capturedevice 160 may include resilient flaps 161 that separate as the needletip passes into the device, and then collapse about the needle hub tohold the needle tip within the cannula 151.

The closure tool 150 further includes a guide tube 154 that extends fromthe guide channel to a corresponding pivoting wing 156. The wingsupports the guide tube so that the end of the tube opens upward towardthe tissue when the wing is in its operative position shown in FIG. 14.The guide tube is formed of a resilient, bendable material that can beessentially folded upon itself when the wing is in its closed orinsertion position (see e.g. FIG. 9 b), or fully unfolded when the wingsare in their removal position (see e.g., FIG. 12 b). In a specificembodiment, the guide tube is formed of a medical grade plastic.

The guide channel 152 and guide tube 154 define a passageway along whicha curved needle assembly 162 passes. The needle assembly includes aneedle tip 164 to which is attached one end of a suture 166, as shown inFIG. 15. The needle tip and suture arrangement may be the same as theneedle tip and suture described above. The needle assembly 162 furtherincludes a pre-curved needle pusher 168. The needle pusher is formed ofa material that can be pre-formed at a particular radius of curvature,as reflected in FIG. 15, but that is flexible enough to be initiallystraightened to pass through the guide channel 152. In accordance withone feature of this embodiment, the needle driver 168 flattens as it ispushed through the guide channel 152 and the upper portion of the guidetube 154. As the needle driver progresses along the guide tube itcontinues to follow the bend in that tube as well as the straightsection of the guide tube along the length of the stabilizer element156. Once the needle driver exits the guide tube 154 beneath the tissuelayers, the driver starts to assume its pre-curved shape. As the needledriver and the needle tip it carries are pushed further into the tissuethe driver continues to assume its pre-curved shape. The curved shape ofthe needle driver 168 is configured so that the needle tip 164 is guidedtoward the capturing device 160 on the outer surface of the cannula 151.

It is understood that once the needle driver has pushed the needle tipinto the capturing device, the tip is disengaged from the driver and thedriver is retracted along the guide tube 154 and guide channel 152. Itis contemplated that the needle driver is sufficiently long so that aproximal end of the driver is accessible outside the incision when thedistal end of the driver carrying the needle tip has contacted thecapturing device 160. In a specific embodiment, only the distal end ofthe needle driver is pre-curved since it is only necessary for thedistal end of the driver to follow this pre-defined curvature to pushthe needle tip and suture through the tissue layers and arrive back atthe cannula 151 of the closure tool 150. Thus, the needle driver caninclude a straight section 170 (FIG. 16) at the proximal portion of thedriver.

In order to facilitate use of the pre-curved needle driver, the needleassembly 162 may be initially provided within a straight sheath 172. Thesheath 172 may mate with the guide channel 152 to facilitateintroduction of the pre-curved portion of the needle driver 168 into theguide channel.

With this embodiment, the guide channel 152 and guide tube 154 arecontinuous—i.e., they are not provided with a suture slot, like the slot113 of the closure tool 70 described above. In this case, the suture 166will pass through the channel 152 and tube 154 even when the closuretool 150 is removed form the incision. One end of the suture will beretained along with the needle tip 164 in the capturing device 160 asthe tool is removed from the incision. The opposite end of the sutureremains free because the suture will be pulled through the tissue as thecaptured end is pulled with the closure tool. Once the tool has beencompletely removed from the incision the suture can be cut at the end ofthe guide tube 154 and at the capturing device 160. The free ends of thesutures can be tied off in a conventional manner. As with the previousembodiments, once the sutures have been passed through the tissue layersand the closure tool retracted from the incision, the tool 150 can bediscarded. Alternatively, a second set of pre-loaded pre-curved needleassemblies can be loaded into the tool and the tool re-introduced intothe incision but rotated by ninety degrees relative to the suturesalready in position.

In the embodiments of the closure tools described thus far, each sutureis passed through tissue at one side of the incision and then drawnthrough the incision itself, as demonstrated by the ligature loops shownin FIG. 13 e. In an alternative embodiment, a single suture passesthrough tissue layers on opposite sides of the incision, with the suturespanning the incision within the body cavity. Thus, in this embodiment,a closure tool 180 is provided with a continuous needle track 188 whichguides a pre-curved needle 194 that is wholly contained within the tool180, as shown in FIGS. 17-18.

As with the prior embodiments, the tool includes a pair of stabilizerelements 182 that can be rotated from a closed position to an operativeposition to a removal position. The actuators of the prior embodimentsmay be used to extend and retract the elements 182; however, in theillustrated embodiment of FIG. 17 a rack and pinion gear approach isutilized. In this embodiment, the pivot mounted end of the stabilizerelements 182 forms a pinion gear 183. A linear rack gear 185 extendsthrough the closure tool 180 and includes rack threads that engage thepinion gear threads. An actuator knob 186 passes through a slot in thetool 180 so that the knob can be used to raise and lower the rack gear185. As the rack gear is raised, it rotates the pinion gears 183 so thatthe stabilizer elements 182 swing away from the body of the tool 180.The slot (not shown) in the closure tool 180 can incorporate detents,like the actuator channel 98 of the tool 70 shown in FIG. 10 b, so thatthe actuator rack gear may be moved in indexed fashion between the threefunctional positions of the stabilizer elements 182.

In accordance with this embodiment of the invention, the closure tool180 defines a continuous needle track 188 that winds around thecircumference of the tool and along the length of the tool. The needletrack is preferably configured to accommodate the pre-curvedconfiguration of the needle 194. For instance, the needle track cangradually spiral up the length of one side of the tool 180 and spiraldown the opposite side. The needle track traverses the body of the tool180 at an exit opening 195 and an entrance opening 198 substantiallyopposite the exit opening. As shown in FIG. 17, the entrance opening 198is larger than the exit opening and forms a taper to the needle track.This feature of the entrance opening helps guide the pre-curved needle194 back into the tool 180 once it has passed through the tissue layerson both sides of the incision, as indicated by the dashed arrows in FIG.17.

The needle track 188 is accessed through a pair of openings 190 and 192.The first opening 190 provides access to the needle 194 to engage asuture 191 to the needle. The needle can incorporate an eye throughwhich the suture may be threaded in a known manner. Alternatively, thesuture may be crimped onto the needle or otherwise fastened to theneedle so that it can be drawn through the tissue layers with theneedle. The opposite opening 192 allows access to the needle after thesuture has been passed through the tissue and has been pulled throughthe needle track 188. The suture can be cut from the needle at thislocation before or after the closure tool has been removed from theincision. At a minimum, the second opening 192 allows for verificationthat the suture has been drawn through the tissue layers and is inposition to close the incision.

In the preferred embodiment, the pre-curved needle 194 is curved so thatit follows its pre-defined curvature as it exits the needle track 188through the exit opening 195, as shown in FIG. 17. As the needlecontinues to curve through the tissue layers, it is self-directed to aguide slot 196 formed in the body of the tool 180. In the preferredembodiment, the guide slot includes an angled upper wall 197 thatcollects the needle tip even if it is slightly offset on its paththrough the tissue. The guide slot 196 is also open at its lower end sothat a suture passing under the angled upper wall 197 is not trappedwithin the tool 180 when it is removed. At a minimum, the guide slot 196is open at its lateral face so that the suture can be dislodged from theslot by a slight manipulation of the closure tool 180 as it is beingremoved from the incision.

Another feature of this embodiment is that the pre-curved needle ismechanically driven by a needle drive assembly 200. In one specificembodiment, the drive assembly 200 includes a pair of drive rollers 202that are arranged to contact the needle 194 at opposite sides of theclosure tool 180. An idler roller 204 is connected to an externallyaccessible crank 206. Rotation of the idler roller rotates the two driverollers in opposite directions, with one roller 202 a propelling theneedle up through needle track 188 and the other roller 202 b pushingthe needle down through the track toward the exit opening 195. Therollers may be formed of a hard rubber that exhibits sufficient frictionto propel the needle along the track. It can be appreciated that theneedle track 188 defines openings at the rollers so the rollers candirectly contact the needle within the track.

In accordance with this embodiment, the pre-curved needle has a lengththat permits at least one of the rollers 202 to be in driving contactwith the needle 194 at all times. Since the pre-curved needle exist andre-enters the needle track, it must have enough length so that theneedle tip encounters one of the rollers 202 a on its return to the tool180 before the tail end of the needle loses contact with the otherdriver roller 202 b. At the same time, the needle track 188 is sizedrelative to the length of the needle so that the needle can be entirelycontained within the closure tool 180 when the tool is inserted into orremoved from the incision.

In an alternative embodiment, a drive assembly 212, configured like thedrive assembly 200, can be situated at the base of a closure tool 210,as shown in FIG. 19. In this embodiment, the tool does not define acontinuous needle track, but instead a discharge track 214 and aretrieval track 216. The drive assembly 212 is disposed between the twotracks to propel or pull a pre-curved needle 220 in the same circularpath through the tissue layers at the opposite sides of the incision.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, the same should be considered asillustrative and not restrictive in character. It is understood thatonly the preferred embodiments have been presented and that all changes,modifications and further applications that come within the spirit ofthe invention are desired to be protected.

For instance, in the various embodiments, a plunger, actuator knob androtating crank have been disclosed for controlling the actuation of thestabilizer elements and for deploying the suture needles and needletips. Other means for controlling the actuation and movement of thesecomponents are contemplated, including reusable devices that areconfigured to mate with the various closure tools. For instance, onealternative is to implement a squeeze handle to advance the sutureneedles through the tissue. In this alternative, the squeeze handlewould include a fixed handle arm engaged to the tubular body of theclosure tool and a movable handle arm connected to the needle driver ina suitable manner. For example, the movable handle arm may be connectedto an end of the needle driver 124 shown in FIG. 13 a through anappropriate linkage so that manually squeezing the handle drives theneedle tip and suture the appropriate distance through the tissue.

As a further alternative, the actuation of the stabilizer elements maybe initiated by a manual trigger through a spring-biased element adaptedto extend the stabilizer wings to their operative position. Preferably,the trigger actuation for the stabilizer elements is combined with thesqueeze handle actuation for the suture needle driver to providesingle-handed operation of the closure tool. Since the closure tool ispreferably disposable, the trigger and squeeze handle actuators may beprovided separately with means for engaging the actuators to the closuretool. After each use, the separate actuator device would be cleaned andsterilized for use in another procedure.

In a further modification, the closure tools may incorporate one or morestabilizer elements or wings, with an appropriate number of needle guidechannels. Alternatively, a single stabilizer wing may be configured torotate relative to the tubular body of the closure tool to align with aplurality of needle guide channels disposed around the circumference ofthe body.

In the illustrations of the preferred embodiments, the closure tool hasbeen described as being used to close a surgical incision. The closuretools of the present invention may have application in closingnon-surgical wounds as well. The stabilizer elements may be used to helpretract the fascia away from internal organs for better visualization todetermine whether any organs require repair. The closure tool can thenbe used to close the wound in the same manner described above.

We claim:
 1. A device for assisting in closure of an incision in tissuelayers of a patient, the device comprising: a tubular body defining alongitudinally extending side wall for introduction through theincision, the tubular body having a distal end portion, a proximal endportion, and a length between the distal end portion and the proximalend portion sized such that the distal end portion may be positionedadjacent an inner surface of an innermost tissue layer while theproximal end portion remains accessible outside the patient; and atleast one stabilizer element movably supported at the distal endportion, the at least one stabilizer element being selectively movablebetween a retracted position to permit insertion of the tubular bodythrough the incision, and a deployed position where the at least onestabilizer element extends laterally away from the tubular body topermit contact with an interior surface of the innermost tissue layer,wherein the tubular body defines at least one guide channel extendingfrom the proximal end portion to the distal end portion for directing aneedle carrying a suture from an entry opening at the proximal endportion through an opening of the at least one stabilizer element suchthat at least a portion of the suture passes through the opening of theat least one stabilizer element.
 2. The device of claim 1, wherein thetubular body further defines a slot extending through the side wall toallow lateral passage of the suture out of the at least one guidechannel while preventing lateral passage of the needle.
 3. The device ofclaim 1, wherein the at least one stabilizer element is pivotallymounted to the distal end portion of the tubular body.
 4. The device ofclaim 3, wherein the tubular body includes a lower edge and at least oneleg extending therefrom, a distal end of the at least one leg defining apivot mount for the at least one stabilizer element.
 5. The device ofclaim 4, wherein the tubular body includes a pair of legs extending fromthe lower edge, and wherein the pivot mount includes an axle extendingbetween the pair of legs, the at least one stabilizer element beingrotatably mounted on the axle.
 6. The device of claim 4, wherein thepivot mount includes a torsion spring engaged between the at least onestabilizer element and the axle, the torsion spring being configured tobias the at least one stabilizer element toward the deployed position.7. The device of claim 1, further comprising an actuator supported atthe distal end portion of the tubular body, the actuator being coupledto the at least one stabilizer element to selectively actuate the atleast one stabilizer element between at least the retracted position andthe deployed position.
 8. The device of claim 7, wherein the actuator isconnected to the at least one stabilizer element via at least oneactuator wire.
 9. The device of claim 1, wherein the at least onestabilizer element includes a pair of wings pivotably mounted toward thedistal end portion of the tubular body.
 10. The device of claim 1,wherein the wings are substantially aligned with the tubular body in theretracted position and extend transversely outward from the tubular bodyin the deployed position.
 11. The device of claim 1, wherein the atleast one stabilizer element is supported toward the distal end portionof the tubular body to be selectively movable to a removal positionwhere the at least one stabilizer element is substantially in alignmentwith the tubular body for removal of the tubular body through theincision.
 12. The device of claim 1, wherein the entry opening isconical to facilitate introduction the needle carrying the suture intothe at least one guide channel.
 13. The device of claim 1, wherein theat least one stabilizer element includes a rigid stabilizer elementconfigured to bear against the tissue from within an insufflatedsurgical site to provide pressure to compress the tissue during sutureinsertion.
 14. The device of claim 1, wherein the at least onestabilizer element includes a retention device at a free end thereof,the retention device including a resilient element that deforms uponpassage of a needle tip of the needle therethrough and is configured toretain the needle tip.
 15. The device of claim 14, wherein the resilientelement includes a plurality of resilient flaps.
 16. The device of claim14, wherein the at least one stabilizer element includes a rigidstabilizer element configured to bear against the tissue from within aninsufflated surgical site to provide pressure to compress the tissueduring suture insertion, and wherein the resilient element is providedwithin the rigid stabilizer element.
 17. A method for assisting in theclosure of an incision in body tissue, the method comprising:introducing a tubular body having a longitudinally extending side wallthrough the incision, deploying a stabilizing element between the bodytissue and body structure adjacent the incision by actuating thestabilizing element to a deployed position, the stabilizing elementincluding an opening, pulling the tubular body away from the bodystructure to contact the body tissue while the stabilizing element is inthe deployed position, and advancing a needle carrying a suture throughat least one guide channel defined by the tubular body to direct theneedle through the opening of the stabilizing element.
 18. The method ofclaim 17, wherein the advancing the needle carrying the suture furthercomprises passing at least a portion of the suture through the openingof the stabilizing element.
 19. The method of claim 17 furthercomprising: capturing the suture with the stabilizing element, andwithdrawing the needle from the at least one guide channel.
 20. Themethod of claim 19 further comprising: retracting the stabilizingelement by actuating the stabilizing element to a retracted positionwhere the stabilizing element is substantially in alignment with thetubular body, and withdrawing the tubular body from the incision withthe suture captured so that the suture forms a ligature through the bodytissue at the incision.